RecruitingNCT04603209

Registry for Intra-Operative Radiotherapy During Breast Conserving Surgery in Patients With Early Stage Breast Cancer

Research Registry for Intra-Operative Radiotherapy (IORT) During Breast Conserving Surgery in Patients With in Situ and Early Stage Breast Cancer

Sponsor

Saint John's Cancer Institute

Enrollment

1,000 participants

Start Date

Oct 3, 2018

Study Type

OBSERVATIONAL

Conditions

Breast Neoplasms Early Stage Breast Cancer Breast Carcinoma in Situ

Summary

This is a prospective, registry study that will enroll all women with early stage breast cancer who will be treated with intraoperative radiotherapy (IORT) during breast-conserving surgery. The purpose of this study is to further validate the long-term effectiveness and safety of this treatment method. We aim to assess short and long-term patient outcomes associated with IORT, including perioperative complications, local and distance disease recurrences, as well as disease-free survival and overall survival.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This registry tracks patients with early-stage breast cancer who receive intraoperative radiotherapy (IORT) — a single high dose of radiation delivered directly to the surgical site at the moment the tumor is removed during breast-conserving surgery. By treating the tumor bed immediately in the operating room, IORT may eliminate the need for several weeks of external radiation sessions after surgery. **You may be eligible if...** - You have early-stage breast cancer that is in situ (confined to the duct), or an invasive tumor up to 3 cm with no lymph node or distant spread (Stage Tis, T1, or T2 ≤3 cm, N0, M0) - Your cancer is in one area only (unifocal disease) - You are a candidate for breast-conserving surgery (lumpectomy) - Your medical team recommends IORT as part of your treatment plan **You may NOT be eligible if...** - Your cancer is larger, has spread to lymph nodes, or has spread to distant organs (Stage T3–4, N1–3, or M1) - You have cancer in multiple areas of the breast (multifocal disease) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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